Air samplers are an important tool in ensuring compliance and an effective environmental monitoring program.

EU GMP places additional emphasis on continuous environmental monitoring now more than ever before. Pharmaceutical manufacturing and industrial labs rely heavily on air samplers, prepared media and validation processes in order to meet compliance.

Regularly measuring the quality of air in controlled environments is critical.  Microbial Air Samplers are therefore an essential tool in any environmental monitoring program, enabling users to refine their EM programs, and to obtain early warning of issues that may require corrective action. Air samplers also play a part in verifying sources of contamination and providing insight into the adequacy of sanitation.

Choosing the best air sampler for your premises and needs means that compliance, efficiency and consistency are met with confidence. Regular calibration ensures that your data is 100% reliable and that your air samplers are performing at their best.

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How microbial air samplers work

Impaction air samplers collect particles onto solid media. When the air hits the collection surface, it makes a tangential change of direction, throwing out suspended particles onto the media. When the required volume of air has passed through the sampling head, the agar plate can be removed and incubated. The number of visible colonies allows a direct quantitative estimate of colony forming units in the sampled volume of air.

 

SIEVE METHOD – SAS AIR SAMPLER

Surface Air Samplers (SAS) use the sieve method to capture particles. Air is drawn into the sampling head and through a perforated sieve onto a static agar plate. The diameter of the sieve holes determines air velocity. As impaction is onto a static plate, a correction factor must be applied to correct for particle duplication at the impaction points.

SLIT TO AGAR METHOD – IMPACTAIR SAMPLER

ImpactAir samplers use the slit to agar sampling method. Air is drawn into the sampling head via a narrow slit and accelerated onto a rotating agar plate. A key benefit is that air is constantly impacted onto a new part of the agar plate, so providing a time related picture of any contamination. They are recommended for continuous environmental monitoring.

Types of air samplers

Differing types of air samplers and monitoring devices are available to suit different applications. Matching the correct instrument to a given need is vital in ensuring reliable EM data is collected.

 

Grade A

ImpactAir and ISO90 air monitors are designed for continuous air monitoring use to meet new Annex 1 requirements in pharmaceutical, healthcare and specialist food industries. The stainless-steel construction can be easily integrated into existing control systems.

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Handheld

SAS handheld samplers are used in pharmaceutical cleanrooms, isolators, operating theatres and food manufacturing. Portable, battery powered and easy to transfer to multiple locations. Designed for easy cleaning and easy deployment for EM sampling needs.

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ISOLATOR CABINET

A variant of handheld SAS devices, these devices are designed to be placed inside the isolator cabinet. Using compact, stainless steel sampling heads these samplers are easy to install and do not require an external vacuum.

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COMPRESSED AIR

Pinocchio air samplers are a further variant within the SAS range. These are non-powered, stainless steel units that are easy to use in controlled spaces to test the microbiological quality of both compressed air and gases.

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Servicing and Support

 

To ensure you can trust the output and data retrieved from your process and samplers, you must have your equipment properly validated and calibrated. In order to meet regulatory compliance machines need to be kept in calibration. By ensuring your air sampler is regularly calibrated, you can remain confident in the knowledge that your sampling data for the previous period is accurate.

We have created a check list of things to do when sending your air samplers in for a service.

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Choosing the best air sampler for your business

One of the most difficult decisions facing a company is knowing which air
sampler they need and the efficiency of the different models.

Factors to consider

  1. The sample size that is needed
  2. Types of samples, number of sample locations and frequency of sampling
  3. The sensitivity of those viable particles to the sampling procedures you have in place
  4. Size and area of the cleanroom for monitoring
  5. The type of business and products (Food industry, pharmaceutical industry, sterile and non-sterile products – all these criteria factor in to which product you need) General vs Critical products
  6. The estimated concentration of the collected particles
  7. The collection efficiency of each sampler
  8. The appropriate prepared culture media you would need to use
  9. The ambient conditions of the area that requires sampling
  10. Whether the sampler has the right airflow velocity for low levels of viable particles
SAS Super Unit in Case
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The Environmental Monitoring Process and Validation Guide

Confused about creating an EM program that fits your business and budget and complies with the latest EU GMP Annex 1 revision?

Our guide will help.

Download Guide

Grade A

The ImpactAir-90 and ISO-90 range of microbial air monitors have been designed to address a key requirement within pharma, healthcare and specialist food industries.  That is to achieve longer sampling periods within grade A environments and minimise risk in these critical zones.

 

They are used for continuous monitoring in high-grade areas, where process monitoring of viable particles can be critical and where ISO-14698, BS EN 17141 and GMP Annex 1 compliance must be satisfied.

 

The ImpactAir-90 and ISO-90 instruments have a chamber for a 90mm Petri dish and use a highly efficient slit to agar method which offers a high degree of confidence in data captured. A 140mm Petri dish version is also available if space is not a constraint.

 

ImpactAir ISO-90 -Low Res
SAS Super Unit Hand Held - low res

Handheld

SAS hand held microbial air samplers are compact, portable, lightweight and reliable. Making them ideal for a wide range of air monitoring applications. They use readily available contact plates, with no need for expensive, specialist consumables. Models that use Petri dishes are also available.

 

SAS Super 100 – For use in lower grade cleanrooms where smaller sample sizes are required.

 

SAS Super 180 – For use in higher grade cleanrooms, isolators, LAF cabinets and operating theatres

 

SAS Super DUO 360 - With two sampling heads, this sampler collects bacterial and fungal samples either simultaneously or sequentially.

 

Isolator Cabinet

Created from handheld air sampler units, SAS Super Isolators presents accurate, reliable and flexible monitoring solutions for isolator cabinets and filling line monitoring. Products are designed to reduce contamination risk and minimise aseptic transfers. No complex fixtures are required for installation and removal for calibration or service is hassle free.

 

Using standard sieve sampling technology, the SAS utilises the proven multi-point impaction method to collect airborne particles.

 

SAS Isolator and Head - low res
SAS Super Pinocchio CR - Low Res

Compressed Air

SAS Super Pinocchio units are non-powered air samplers that provide a controlled method for bioburden monitoring of compressed air and other gases and can be included in an environmental monitoring program. Sampling is, therefore, not constrained by the availability of power or high-risk environments, for example flammable gases.

 

Using the proven SAS method of viable air sampling, these samplers collect air samples onto contact plates or Petri dishes. Designed to be robust, compact and easily dismantled for cleaning, units are ideal for use in manufacturing facilities where compressed air monitoring is placed under tighter regulations and investigation.

 

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FREQUENTLY

Asked Questions

How much air should we sample?

Typical requirements suggest 1,000 litres per air sample in high risk areas, such as: grade A filling lines, grade B clean rooms, operating theatres etc. As the criticality of the area reduces, the sample size can be reduced. The aim is to achieve a representative sample; so, where higher counts would be expected, a smaller sample produces a more realistic number of cfu to count.

Can I autoclave my SAS sampler?

No do not put your SAS Sampler in a steam autoclave. The only part that can be autoclaved is the drilled head. The unit can be wiped with alcohol wipes to decontaminate it. The only other exception is the SAS Pinocchio, parts of which can be autoclaved.

How frequently should my SAS air sampler be calibrated?

Cherwell Laboratories recommends every 12 months and we will send a reminder for the month it is due. For some situations local procedures demand more frequent recalibrations so Cherwell is happy to offer tailored recalibration date labelling and reminders on request.

Should I use contact plates or Petri dishes in my air sampler?

SAS samplers were originally designed for Contact plates, however, a Petri dish option has been available for a number of years. It is really a personal choice, although this should be decided at time of purchase, as the sampler will be specifically configured for the plate type chosen. There are advantages for each version and we would be happy to discuss your specific needs.

How many air samples should we take?

This is a common question to which there is no simple answer. The new Annex 1 focuses on risk based approach to monitoring and as such the number of samples needed for an EM program will vary depending on size of room, grade of room, type of tasks being performed, presence of operators and level of containment between product and other risks. All of these factors need to be borne in mind when designing your program, as well as considering the equipment being used.

What is the maximum volume of air that can be sampled onto one plate?

The medium in a Contact plate or Petri dish is predominantly made up of water, agar is the setting agent. This water content is vital for promoting the growth of colony forming units into visible organisms. Therefore, over sampling can dehydrate the medium and potentially cause low recovery. As most standards or guidelines for clean rooms express limits as colony forming units per cubic metre, we have always recommended one cubic metre or 1000 litres as the maximum sample size per plate.

What should be returned for calibration of an air sampler?

When calibrating your air sampler, we will also service the unit to ensure it is functioning correctly. As a minimum we require the sampler unit (and sampling head in the case of the Isolator version) with a drilled head to calibrate. However, we recommend return of the charger and that these items are all packed in one of the SAS carry cases for maximum protection during transit. It is also very helpful if customers complete a returns form so we know who the units is from.